Patient Specific Guide Wire Method

ABSTRACT

A guide wire control device and methods of use are described herein. A novel method for optimizing a guide wire for a patient is described. The method includes steps of scanning a patient&#39;s anatomy and then fabricating, or selecting, a guide wire with optimal geometry for a particular patient and/or procedure. The guide wire may optionally be secured to a guide wire control device for improved control during transcatheter surgical procedures.

CROSS REFERENCE TO RELATED APPLICATION

I hereby claim benefit under Title 35, United States Code, Section 120of U.S. patent application Ser. No. 15/005,520 filed Jan. 25, 2016entitled “Catheter Guide Wire Control Device”. This application is acontinuation of the Ser. No. 15/005,520 application. The Ser. No.15/005,520 application is currently pending. The Ser. No. 15/005,520application is hereby incorporated by reference into this application.

STATEMENT REGARDING FEDERALLY SPONSORED R&D

Not related to this application.

TECHNICAL FIELD

This invention relates to guide wire control devices, and moreparticularly to guide wire control devices for use in proceduresinvolving catheter deployed medical devices.

BACKGROUND OF THE INVENTION

Guide wires are commonly used in the field of medicine. They are used tonavigate the torturous pathways of anatomy. Guide wires, also calledstylets, can be inserted through an orifice of a body, or surgicallyinserted. The wire is pushed, turned, and flexed at a proximal end whichremains outside the body. The forces applied to the proximal endtranslate down the wire to a distal end. The distal end can providevarious procedure specific functions inside the body. A guide wire canbe made from various materials, with metal being common. Guide wiresalso come in a wide range of diameters, typically being 0.050 inches orless. Guide wire coatings and finishes can provide benefits for a givenprocedure. A common application for a guide wire is with endovascularprocedures.

The practice of repairing an artery through the use of a stent is wellknown in the field of medicine. In general and as an example of atypical guide wire application, a guide wire is inserted into an arteryusing the Seldinger technique. The femoral artery, near the groin, is acommon entry point. The guide wire is advanced to a desired location. Adelivery catheter with a stent attached is placed around the guide wirethrough a central lumen and is advanced along the length of the guidewire. Depending on the type of stent, the stent may be deployed byexpansion of a balloon or in the case of nitinol stents, by withdrawinga sheath covering the nitinol stent and allowing the nitinol stent toassume its memory shape through self-expansion. A well known issue withself-expanding nitinol stents is their tendency to “jump” as the sheathon the delivery catheter is retracted, which limits the precision of thestent deployment and can result in malposition of the stent. Once thestent is deployed, the delivery catheter is removed from the body.

A recent advancement in the treatment of cardiac disease istranscatheter devices to either replace or repair dysfunctional nativecardiac valves. These include the aortic, mitral, tricuspid andpulmonary valves. Rather than using an open heart procedure to replaceor repair a defective valve in a patient's heart, a minimally invasivecatheter system is used to deploy an expanding structure containing areplacement valve material. The new prosthetic valve displaces theleaflets of the defective valve and takes over the function ofregulating blood flow through the heart and artery. Transcatheterprosthetic valve technology is dominated by two technologies. The firstuses a stainless steel (or other metal composition) stent that isexpanded by an inflatable balloon. The second utilizes a nitinolmetallic mesh that is cooled and compacted, and then expands to adesired shape when the metal approaches body temperature.

Transcatheter valve replacement presents marked challenges over otherendovascular procedures that utilize a catheter. Unlike typicalendovascular procedures which occur in constrained tubular blood vesselswhere there is limited spatial movement of the devices, transcathetervalve procedures by their nature are performed in the heart withrelatively large and spatially complicated chambers that posesignificant challenges to guidewire management and device manipulationby the surgeon. First, the prosthetic valve must be located extremelyprecisely relative to the natural valve prior to the prosthetic valvebeing expanded in place. The replacement valve needs to be located plusor minus 1-3 mm in depth relative to its target location. The surgeonmay use fluoroscopic imaging to determine optimal depth of the valveprior to deployment. From the proximal end, the surgeon manipulates theguide wire and catheter sheath to achieve the desired deploymentlocation of the prosthetic valve. An improperly deployed valve can leadto perivalvular regurgitation or catastrophic embolization of the deviceinto either the heart or aorta. Second, in order to minimize canting ofthe prosthetic valve, the deployed valve should be positioned ideally inthe center of the diseased native valve. Again, the surgeon uses forceson the proximal end of the guide wire and catheter to attempt tomanipulate the location of the valve relative to the walls of thedefective valve. Third, during the procedure the surgeon in addition tomaintaining optimal forces on both the catheter sheath and guide wire,has additional responsibilities of managing the operating room, andscanning fluoroscopic, echocardiology and hemodynamic monitors. When thereplacement valve is optimally located, the surgeon must maintainoptimal pressure on both the guide wire and the catheter to resisttranslational forces created by the expanding valve. Wherein manyendovascular procedures utilize the guide wire only for navigationpurposes, in new advanced procedures such as transcatheter aortic valvereplacement, the guide wire is often the key element throughout theprocedure and requires constant attention. The transcatheter aorticvalve replacement guide wire provides navigation of the catheter sheathas well as impacting location of the deployed valve. With guide wiresbeing small in diameter, often coated in low friction materials, andwith bodily fluids present, maintaining optimal pressure on the guidewire throughout the valve replacement procedure can be challenging andfatiguing for the surgeon. Although the field of transcatheter mitralvalve replacement and repair is less mature than transcatheter aorticvalve replacement, the challenges of accurate device deployment may beeven greater due to the factors outlined above.

In these respects, the present invention departs from conventionalconcepts of the prior art by providing a guide wire control device foruse in catheter based medical procedures. The present invention alsoprovides an improved way to achieve optimal valve deployment intrancatheter valve replacement and repair procedures.

SUMMARY OF THE INVENTION

The present invention takes a very different approach to controlling aguide wire during medical procedures in comparison to the prior art.

The present invention provides a device for controlling a guide wireduring a surgical procedure. A guide wire is retained by a lockmechanism to a translational assembly. The translational assembly movesrelative to a stationary assembly. The movement of the translationalassembly, and resulting guide wire, is controlled by the interaction ofa spring device that engages with an array of features in the stationaryassembly. The angle of engagement of the spring device to the stationaryassembly can be changed to provide optimal translational resolution andoverall movement. The stationary assembly may be attached to a catheterdelivery device or the two can be integrated.

Control of a guide wire, according to the present invention, providesthe advantages of reducing fatigue of the surgeon and better locationalaccuracy of catheter delivered medical devices. The preferredembodiments for both the apparatus and process is described for use inheart valve repair and replacements, but the present invention isapplicable to any medical procedure utilizing a catheter.

Also described in the present invention are improved guide wire shapesthat are optimized for procedures that utilize a guide wire for not onlynavigating tortuous lumens, but for also providing structure for usewithin open cavities such as the heart. The present invention providesguide wire distal end shapes and a process for customizing a guide wirefor use with a particular patient's heart. Although described for use inheart valve replacement and repairs as part of the best mode of thepresent invention, optimizing guide wires as described herein isapplicable to any guide wire based medical procedure.

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention are described below with thereference to the following accompanying drawings:

FIG. 1 is a front partial section view of a heart with a guide wireinserted through the aortic artery and into the left ventricle of theheart.

FIG. 2 is the same front partial view as FIG. 1, but with a cathetersheath and artificial valve inserted around the guide wire of FIG. 1 andinto the heart.

FIG. 3 is the same front partial section view of FIG. 1 and showing adeployed artificial valve.

FIG. 4 is a perspective view showing a distal end of a prior art heartvalve deployment device.

FIG. 5 is a top view of a proximal end of a prior art heart valvedeployment device.

FIG. 6 is a perspective view of a guide wire control device, accordingto the present invention. The guide wire control device is attached tothe end of the heart valve deployment device of FIG. 5.

FIG. 7 is a perspective view of the guide wire control device of FIG. 6and showing a stationary assembly separated from a translating assembly.

FIG. 8 is a side view of the guide wire control device of FIG. 7 andshowing the stationary assembly detached from the translating assembly.

FIG. 9 is a front perspective view of the translating assembly,according to the present invention, and showing section line C.

FIG. 10 is a front perspective and exploded view of the stationaryassembly of the present invention.

FIG. 11 is a bottom perspective view of the groove member of thestationary assembly and showing detail area 11 b.

FIG. 11B is a detailed perspective view of the groove member of FIG. 11.

FIG. 12 is a section view of the guide wire control device in thedirection of section arrow C of FIG. 9.

FIG. 13 is a rear perspective view of a spring according to the presentinvention.

FIG. 14 is a rear perspective view of an actuator that fits within thestationary assembly.

FIG. 15 is a section view of the translating assembly inserted into thestationary assembly. The view is sectioned through the middle of thewire control device. Also shown is detail area 15 a.

FIG. 15a is a detailed view of FIG. 15 and showing the interaction of atine of the spring engaged with the groove member of FIG. 11.

FIG. 16 is a perspective view of translational assembly showing analternative embodiment guide wire lock mechanism. The translationalassembly is shown with the nearest main body hidden to better shown thealternative embodiment lock components.

FIG. 17 is a front partial section view of a heart showing theapplication of an alternative embodiment guide wire end shape forimproved alignment of a heart valve.

FIG. 18 is an offset guide wire alternative embodiment shape.

FIG. 19 is a variable length guide wire alternative embodiment shape.

FIG. 20 is a bent guide wire alternative embodiment shape.

FIG. 21 is a curl guide wire alternative embodiment shape.

FIG. 22 is a front partial section view of a heart showing theapplication of an alternative embodiment guide wire having a pluralityof strands.

FIG. 23 is a section view of the plurality stranded guide wire of FIG.22.

FIG. 24 is a flow diagram for a custom guide wire process.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Many of the fastening, connection, wiring, control, manufacturing andother means and components utilized in this invention are widely knownand used in the field of the invention, and their exact nature or typeis not necessary for a person of ordinary skill in the art or science tounderstand the invention; therefore they will not be discussed indetail. Furthermore, the various components shown or described hereinfor any specific application of this invention can be varied or alteredand anticipated by this invention and the practice of a specificapplication or embodiment of any element may already be widely known orused in the art, or persons skilled in the art or science; therefore,each will not be discussed in significant detail.

The present invention, as described, is used to control guide wiresduring medical procedures. Guide wires can be used to navigate tortuouspathways, can be used in advance of a delivery catheter, or used inconjunction with a delivery catheter to perform a desired medicalprocedure. Although the present invention is primarily described for usewithin an aortic artery, it should be appreciated that the presentinvention should not be construed to be limited to any particular bodylumen. Other applicable lumens include, but are not limited to,gastrointestinal and urine lumens. Similarly, the present invention isprimarily described for use with heart valve replacement procedures, butthe present invention should not be construed to be limited to anyparticular procedure. Other applicable procedures include, but are notlimited to, coronary angioplasty, stenting procedures and angiograms.

Now referring to the figures, FIGS. 1, 2 and 3 show a partial sectionview of a heart 10. The anatomy of heart 10 is well known in the art ofmedicine and a detailed understanding is not necessary for one tounderstand and appreciate the present invention; therefore it will notbe described in significant detail. Components of heart 10 shown in theaccompanying drawings are in the non-limiting context of using thepresent invention in an aortic valve replacement procedure.

In replacing an aortic valve and referring to FIG. 1, a guide wire 30 isadvanced through an aortic artery 12, through a natural aortic valve 16,and into a left ventricle 18. Aortic artery 12 starts in the abdomen. Anaortic arch section 14 comes from the back side of the heart and bendstowards an ascending aorta section 15 which is just before aortic valve16. Blood leaving left ventricle 18 escapes through natural aortic valve16. Aortic valve 16 is surrounded by an aortic valve annulus section 17.It should be appreciated that the lumens of heart 10 are complex inshape and trajectory.

FIG. 4 shows the distal end of a prior art heart valve replacementdelivery system. Although the present invention is not limited to anyparticular delivery system, one such system is commercially produced byMEDTRONIC® under the tradename COREVALVE®. Guide wire 30 has a guidewire distal end 32 which is shown manufactured with a curl. Guide wire30 is approximately 0.035 inches in diameter and made from a metallicmaterial which is coated in a low friction material, such aspolytetrafluorethylene. Guide wire distal end 32 is more flexible thanthe rest of guide wire 30 which allows it to more easily navigatetortuous pathways with minimal damage to adjacent tissue. A cathetersheath 40 is advanced over guide wire 30. Catheter sheath 40 isconnected to a capsule 44 which houses a prosthetic valve 42. In FIG. 4,prosthetic valve 42 is shown in a partially deployed state. Withadvancement of catheter sheath 40, prosthetic valve 42 is completelyencapsulated within capsule 44. With retraction of catheter sheath 40,prosthetic valve 42 is deployed.

The application of the prior art heart valve delivery system of FIG. 4is shown in FIGS. 1, 2 and 3. In FIG. 1, guide wire 30 has been advancedthrough aorta 12, has navigated both aortic arch 14 and ascending aorta15 sections, has penetrated though natural valve 16, and has guide wiredistal end 32 located within left ventricle 18. The curve of distal end32 is shown against a wall of left ventricle 18 which can provide someforce against guide wire 30. It should be appreciated at the stage ofFIG. 1, the surgeon has advanced guide wire 30 by applying forces to theproximal end of guide wire 30. Imaging and feel ensures guide wire 30 isproperly placed in heart 10. Guide wire 30, when placed in heart 10, hassome impact to the normal function of heart 10. Therefore, it isdesirable for the surgeon to act quickly and precisely to deployprosthetic valve 42.

FIG. 2 shows catheter sheath 40 advanced over and along guide wire 30.Because guide wire 30 is used in conjunction with catheter sheath 40 tolocate prosthetic valve 42 in its optimal location, it should beappreciated that the surgeon may have to move guide wire 30 inrelationship to catheter sheath 40. Optimal location of prosthetic valve42 in relationship to natural valve 16 and aortic annulus section 17 maybe plus or minus one to three millimeters. Once optimal location ofprosthetic valve 42 has been achieved both radially and in depth, thesurgeon retracts catheter sheath 40 causing deployment of prostheticvalve 42. The angled expansion of prosthetic valve 42 can cause a “jump”translation of either catheter sheath 40, guide wire 30, or both, duringdeployment. Translations during deployment can negatively impactdeployment of prosthetic valve 42. To maintain a successful deploymentof prosthetic valve 42, the surgeon must maintain optimal locations andforces of both catheter sheath 40 and guide wire 30. FIG. 3 showsprosthetic valve 42 deployed.

FIG. 5 shows a prior art heart valve deployment device 50 which controlsthe advancement of sheath 40 and deployment of prosthetic valve 42. Thesurgeon holds heart valve deployment device 50 via deployment devicehandle 54. Prosthetic valve 42 is deployed by turning a deploymentactuator 52 relative to deployment device handle 54. Guide wire 30translates through deployment device 50 and exits through a Luer fitting56. During a prior art procedure, the surgeon must maintain optimalforces on guide wire 30 and manage its location with respect todeployment device 50. Managing guide wire 30 relative to deploymentdevice 50 is done with whatever available or remaining fingers thesurgeon has during the procedure.

FIG. 6 shows a guide wire controller 60 according to the presentinvention. Guide wire controller 60 is shown attached to deploymentdevice 50. Guide wire controller 60 is used to achieve and maintainoptimal position of guide wire 30 in heart 10 and with respect tocatheter sheath 40. Guide wire controller 60 provides the means ofmaintaining a position of guide wire 30 in the tortuous pathways of abody.

As shown in FIG. 7, guide wire controller 60 is comprised of astationary assembly 70 and a translational assembly 80. Stationaryassembly 70 is removably attached to deployment device 50 by connectinga corresponding Luer connector 72 to Luer fitting 56 of deploymentdevice 50. Translational assembly 80 attaches to guide wire 30 by meansof guide wire lock 84. Translational assembly 80 is inserted intostationary assembly 70 and the relative movement between themcontrolled. The result is that translational assembly 80 controls thetranslation of guide wire 30 relative to deployment device 50.

Stationary Assembly

Stationary assembly 70 is best seen in the exploded view of FIG. 10. Amain tube 76 provides the primary structure of housing translationalassembly 80. Main tube 76 is open on both of its ends and containsfeatures for engaging with translational assembly 80. Translationalassembly 80 is able to translate axially through main tube 76 but is notable to rotate with respect to main tube 76. Although the presentinvention should not be limited to any particular dimension or shape ofany particular component, it has been found and according to the bestmode of the present invention, main tube 76 is approximately 4 inches inlength and has an outside diameter of 0.75 inches. ABS type plastic,with a wall thickness of 0.06 inches has been found to be acceptablyrigid, but other materials and wall thickness may be used within thesprit and scope of the present invention. For example, metallicmaterials may be acceptable for use. Preferably, main tube 76 includesfinger support 77 which aids the user in using guide wire control device60.

As shown in FIG. 10, the top of main tube 76 contains an open channel 73which is approximately 0.25 inches wide. Open channel 73 is used to bonda groove cap 78. As best shown in FIGS. 11 and 12, the underside ofgroove cap 78 contains a first array of grooves 79 a and a second set ofgrooves 79 b. Groove arrays 79 a and 79 b are used to engage with aspring 110 of translational assembly 80 which will be later described infurther detail. Groove arrays 79 a and 79 b are cavities that preferablyextend partially through the thickness of groove cap 78. Although cubicsections are shown, it should be appreciated that any shape of cavitycan be used within the present invention. The spacing of groove arrays79 a and 79 b correspond with the desired movement accuracy oftranslational assembly 80 and resulting guide wire 30 relative to maintube 76. According to the best mode of the present invention whereindesired translational accuracy of guide wire 30 and prosthetic valve 42is single millimeters or less, grooves 79 a is shown staggered to groove79 b. With limitations in both strength and manufacturability of groovecap 78, staggering grooves 79 a and 79 b provides the means for creatingtranslational accuracy greater than a single array of grooves ormultiple sets of aligned grooves. Manufacturing strong alternating wallshaving less than one millimeter in width can be at best challenging.Although staggered grooves is primarily described herein as part of thebest mode of the present invention, it should be appreciated that asingle set of grooves may be acceptable for a given procedure or device,all within the spirit and scope of the present invention. Groove cap 78has a central channel 78 a which extends substantially the length ofgroove 78. Central channel 78 a contributes to the guide structure fortranslational assembly 80.

Bonded to the front of main tube 76 is tube ring 74. Tube ring 74provides both manufacturing flexibility to main tube 76 and providesadditional strength to main tube 76. On the forward surface of tube ring74 is Luer connector 72. Luer fittings are common in the art of medicaldevices and Luer connector 72 may be any type of common fitting rangingfrom threaded, fastened with a nut behind tube ring 74, or can be eithermale or female. Many standard Luer fittings are commercially availablefrom the Nordon® Corporation.

Combined, stationary assembly 70 is able to be removably attached todeployment device 50, provides controlled axial movement oftranslational assembly 80, and rotational constrains translationalassembly 80. Although the components of stationary assembly 70 are shownas separate attachable elements that help optimize manufacturing, itshould be appreciated that stationary assembly 70 may be a singlestructure. For instance, a 3D printed version of stationary assembly 70may include groove cap 78, tube ring 74, and other features that arecreated together. The present invention should not be construed to belimited to separate and attachable components.

Translational Assembly

Translational assembly 80 provides controlled movement of guide wire 30relative to stationary assembly 70. Translational assembly 80 has afirst sliding member 86 a and a second sliding member 86 b. Firstsliding member 86 a is a near mirror image of second sliding member 86 bwith the exceptions of a plurality of fastener recess pockets 85 a insecond sliding member 86 a and a plurality of fastener holes 85 b in theback of sliding member 86 a. Screw fasteners are retained by threads infastener holes 85 b. Fastener recess pockets 85 a are sized to ensurethat the fastener heads do not extend beyond the outside surface offirst sliding member 86 a. A stop edge 89 is formed by mating first andsecond sliding member 86 a and 86 b. Stop edge 89 is used to makecontact with the back edge of stationary assembly 70 and to limit thetravel of guide wire 30 relative to stationary assembly 70. Through thecenter of both first and second sliding member 86 a and 86 b is acentral channel 81 which is sized larger than guide wire 30. Centralchannel 81 allows for guide wire 30 to be easily inserted through guidewire controller 60.

Sandwiched between first and second sliding members 86 a and 86 b arecomponents which both capture guide wire 30 and provide controlledmovement between stationary assembly 70 and translational assembly 80.These components are best seen in FIGS. 9, 13, 14 and 15.

A spring 110 is captured by the assembled sliding members 86 a and 86 b.A spring retaining slot 119 matches a corresponding protrusion insliding members 86 a and 86 b. Retaining slot 119 ensures that spring110 cannot move up or down when assembled. To remove the complexity ofmanufacturing a slot the thickness of spring 110 (0.010 to 0.020inches), a removable spring holdback block 120 is placed on the backside of spring 110. The result is that spring 110 is captured and fixedby assembled sliding members 86 a and 86 b. With spring 110 extendingacross central channel 81, a spring opening 118 allows guide wire 30 topass through spring 110. Spring 110 has a first spring tine 112 and asecond spring tine 114. A tine slot 116 enables first spring tine 112 tomove independently of second tine 114. Spring tines 112 and 114 are bentat an angle of “a” to the main section of spring 110. Spring tines 112and 114 may be formed offset to each other as shown in FIG. 13, oralternatively can be formed in the same plane. The reasons foroffsetting are discussed later in the assembly section. Although thepresent invention should not be construed to be limited to anyparticular size or shape of spring, according to the best mode, spring110 is 0.015 inches thick, 0.25 inches wide and made from heat treatedspring steel.

An actuator 100 is best shown in FIG. 14 and FIG. 15. Actuator 14 has apin 104 that is captured by a corresponding cavity in sliding members 86a and 86 b. Actuator 100 acts as a lever that makes contact with spring110 at actuator contact surface 105. The distance between actuator pin104 and actuator contact surface 105 relative to the users thumbdetermines how much force is applied by actuator spring contact surface105 onto the first and second spring tines 112 and 114. At the top ofactuator 100 is where a user engages their thumb or finger forcontrolled movement of translational assembly 80. A push surface 106 atthe front of actuator 100 allows the surgeon to move translationalassembly 80 forward and extend guide wire 30. Push surface 106 is curvedupward to partially capture the users thumb in the event that fluidshave made actuator 100 slippery. When applying a force on push surface106, contact surface 105 does not push down spring tines 112 or 114.Below push surface 106 is actuator guide 102. The width of actuatorguide 102 is just slightly narrower than the width of central channel 78a of groove cap 78. Actuator guide 102 facilitates proper alignment ofactuator 100 relative to main tube 76. Generally above spring contactsurface 105 is a release surface 107. When a user pushes down on releasesurface 107, contact surface 105 applies a downward force on springtines 112 and 114. Behind release surface 107 is a combination surface108. When a user applies a force to surface 108, a slight change in theangle of force can cause contact surface 105 to apply a lateral force totranslational assembly 80, a vertical force onto spring tines 112 and114, or both a lateral and vertical force.

At the back end of translational assembly 80 is a lock 84. As shown inthe cross section of FIG. 12, lock 84 contains and captures a hex headedscrew 83. Screw 83 engages with threads of first sliding member 86 awhich allows screw 83 to move radially towards guide wire 30. Captive tofirst and sliding members 86 a and 86 b is a friction sleeve 71.Friction sleeve 71 is preferably a cylinder made from a high frictioncompliant polymer that both protects guide wire 30 form deformation fromscrew 83 and creates a high friction surface against it. Friction sleeve71 preferably has a length long enough to cover the diameter of screw 83and a central hole capable of passing guide wire 30 when in the relaxedstate. With a PTFE coated guide wire material having a very lowcoefficient of friction, there is a need for approximately 100 pounds ofradial force needed to secure guide wire 30 to translational assembly80. Utilizing a fine pitch, such as but not limited to 32 threads perinch, has been found to provide acceptable grip on guide wire 30 whilerequiring an acceptable turning force on lock 84.

The interaction of translational assembly 80 with stationary assembly 70is best shown in FIGS. 15 and 15 a. First spring tine 112 is shownengaged with first array of grooves 79 a. The angle “a” of spring 110enables first spring tine 112 to deflect downward when translationalassembly 80 moves forward, without any downward force from actuator 100.During forward movement, first spring tine 112 moves up and down fromgroove to groove of first groove array 79 a. In a similar fashion,second spring tine 114 engages with second array of grooves 79 b. Bystaggering engagement of first spring tine 112 to first array of grooves79 a and second spring tine 114 to second array of grooves 79 b, eitherfirst or second spring tine 112 and 114 is always engaged in a groove.Although forward movement of translational assembly 80 with respect tostationary assembly 70 causes spring tines 112 and 114 to flexiblyengage, backward movement is resisted. A backward force on translationalassembly 80 is transferred up through spring 110 and either tine 112 or114 pushes against a groove in groove array 79 a or 79 b. With groovearrays 79 a and 79 b only partially extending through groove cap 78,spring tines 112 and 114 are vertically captured and can takesubstantial forces. A downward force on actuator 100 causes actuatorsurface 105 to push down spring tines 112 and 114 and disengage themfrom groove arrays 79 a and 79 b.

Use

There are several scenarios for use of the present invention. As onegeneral example, the proximal end of guide wire 30 is inserted throughLuer connector 72 of stationary assembly 70. In this scenario,translational assembly 80 is already inserted into stationary assembly70. Guide wire 30 is pushed through translational assembly 80 with lock84 in a screwed outward position. Translational assembly 80 ispreferably in the back position of stationary assembly 70 with eithertine 112 or 114 engaged in the first grove of either groove array 79 aor 79 b. The user then optionally attaches stationary assembly 70 todeployment device 50 by securing Luer connector 72. With guide wire 30loose, the user can push or pull guide wire 30 through guide wirecontroller 60. When guide wire 30 is close to the desired locationwithin a lumen of the body, turning lock 84 applies a grip pressure onguide wire 30 causing it to move with translational assembly 80. Theuser than advances translating assembly 80 forward by applying a forceto either push surface 106 or combination surface 108. The forward forceapplied to actuator 100 causes spring tines 112 or 114 to deflect downdue to angle “a”. Angle “a” disengages spring tines 112 or 114 withforward motion in increments of the combined pitch of groove arrays 79 aand 79 b. The repeated engagement of spring tines 112 and 114 provideboth tactile and audible feedback with the movement of translationalassembly 80. When a desired location is achieved, the user can removepressure on actuator 100 and guide wire 30 stays in the desired locationdue to one of tines 112 or 114 being always engaged and resistingbackward translation. With guide wire 30 secured, the user can focus onother areas of the procedure in progress, and then return to advancingor retreating guide wire 30 as needed through the use of guide wirecontroller 60. At any time, or after guide wire 30 is no longer neededin the given procedure, the user applies a force to release surface 107or combination surface 108 which causes first or second tines 112 and114 to disengage with first or second groove array 79 a and 79 b. Withspring tines 112 and 114 disengaged, the user may completely removetranslational assembly 80 from stationary assembly 70 and pull guidewire 30 out the body lumen, or the user can unsecure guide wire 30 fromtranslational assembly 80 by loosening lock 84 and pull guide wire 30through guide wire control device 60. Alternatively, the user can alsodecouple guide wire control device 60 from deployment device 50 throughLuer connector 72 and pull guide wire 30 by means of guide wire controldevice 60.

Guide wire control device 60 provides substantial guide wire control andimproved deployment accuracy of prosthetic valve 42 during a heart valvereplacement procedure. Guide wire 30 can be advanced through a lumen ofthe body and then inserted through guide wire control device 60, or itcan be advanced through guide wire control device 60 with lock 84 in theunsecured state. With guide wire in the general desired location withinheart 10, translational assembly 80 is engaged to stationary assembly 70as previously described. With catheter sheath 40 advanced to the generaldesired location of capsule 44 within heart 10, the user applies a forceto actuator 100 to move translational assembly 80 and resulting guidewire 30 to adjust capsule 44 to the precise location, both in depth andradially inside of natural valve 16. This movement may be a forwardforce to actuator 100 to sequentially engage spring tines 112 and 114 togroove arrays 79 a and 79 b, or to apply a downward force to actuator100 to disengage spring tines 112 and 114 and to allow translationalassembly 80 and guide wire 30 to move backward. Once prosthetic valve 42is in the desired precise location, valve 42 is deployed with guide wirecontrol device 60 resisting the “jump” force of valve 42 duringdeployment. With the successful deployment of valve 42, guide wire 30can be removed from the body utilizing one of the methods previouslydescribed. At any time during the procedure, if guide wire 30 needs tobe quickly removed from the body or substantially retracted, the surgeoncan quickly apply a downward force to actuator 100 and pull backwardguide wire 30. The open back end of stationary assembly 70 provides themeans to quickly decouple guide wire 30 from stationary assembly 70.

Alternative Embodiments

Although the preceding descriptions set forth the best mode of thepresent invention there are numerous alternative embodiments that allfall within the spirit and scope of the present invention.

The best mode of the present invention utilizes alternating groovesarrays which provide translational resolution that exceeds theresolution that grooves can be produced utilizing low cost manufacturingmethods, such as injection or die cast molding. With some applicationsnot requiring narrow translational resolution, it may be advantageous touse a single array of grooves. The present invention can utilize asingle array of grooves, two arrays that are aligned, or two arrays thatare offset. It is possible to use three or more arrays of grooves toachieve very finite resolutions if needed for a particular procedure.The present invention should not be construed to be limited to anyparticular number of groove arrays or their offsets.

Similar to the alternating groove description above, the presentinvention utilizes two offset tines for independent motion andengagements with groove arrays 79 a and 79 b. The best mode is providedto highlight a high level of design flexibility. Offset tines can beused with aligned groove arrays, or spring 110 can have a single tineengaging with a single groove array. For increased translationalresolution, spring 110 can have more than two spring tines each engagedwith a corresponding groove array. The present invention should not beconstrued to be limited to any particular number of spring tines oroffsets.

As shown best in FIG. 9 and FIG. 12, the best mode of the presentinvention shows lock 84 with screw 83 for applying a radial force toguide wire 30. Screw 83 provides a substantial mechanical advantage andwith complaint sleeve 71 they create a large frictional force on guidewire 30. Such a configuration is desirable with guide wire 30 coatedwith a low friction coating. The best mode of the present invention iscapable of creating a 10 to 20 plus pound retention force on a coatedguide wire. FIG. 16 shows an example alternative embodiment of lock 84.An alternative sliding member 205 is shown having a conical cavity 204and an outside thread 203. Conical cavity 204 engages with a collapsingring 202 that when a turn cap 201 engages with outside thread 203creates a friction force between collapsing ring 202 and guide wire 30.Turning cap 201 can create a variable frictional force onto guide wire30 by pushing collapsing ring 202 into conical cavity 204. Thisalternative embodiment has advantages of greater translationcapabilities as cap 201 can be sized to fit within the inside diameterof main body 76. Other embodiments are cable of creating the neededguide wire frictional forces, such as a locking cam, snap ring oradhesive.

To clarify the sprit and scope of the present invention, it should beappreciated that the angle “a” of spring 110 can altered to provideoptimal function of a give procedure. Angle “a” is shown greater thanninety degrees to allow it to bend downward out of groove arrays 79 aand 79 b with a forward force on actuator 100. Alternatively, angle “a”can be made to be less than ninety degrees which would cause spring 110to resist forward movement of translational assembly 80 but allow rewardtranslation. Furthermore, angle “a” can be approximately ninety degreeswhich would not allow any sliding movement of translational assembly 80without actuator 100 causing spring 110 to deflect out of groove arrays79 a and 79 b. The best mode for angle “a” is shown at 125 degrees, butany angle falls within the sprit and scope of the present inventionproviding controlled movement of guide wire 30.

The best mode of the present invention is shown as an add on to existingdeployment device 50. It should be appreciated that the advantages ofthe present invention is not limited to it being an add on device.Rather than utilizing a Luer fitting for connecting two devices, it maybe desirable to build the present invention into deployment device 50. Acommon housing can have a groove array and allow for the controlledmovement of translational assembly 80.

FIGS. 17 to 21 show alternative shapes of guide wire 30 which can beused to more optimally center prosthetic valve 42 within heart 10. Guidewire 300 is shown with a complex shape that has bends that can makecontact with the walls of heart 10 to better align guide wire 10 andprosthetic valve 42 within annulus 17. An offset section 304 is shownhaving an angle 301 with respect to annulus 17. Offset section 304creates a staggered distance for a contact section 305 to make contactwith the left interior wall of the patient's heart. Contact section 305is at an angle 302 with respect to the axis of annulus 17. Combined, aforce on the proximal end of guide wire can apply a force between theinterior surface of left ventricle 18 and contact section 305 whichresults in a radial location change of guide wire 30 through naturalaortic valve 16. By translating guide wire 30 relative to sheath 40 anoptimal location of prosthetic valve 42 can be more easily and quicklyachieved over the prior art.

FIGS. 18 through 21 show more alternative embodiments of guide wire 30with any one being optimal for a particular patient's heart. FIG. 18shows offset guide wire 500 having an offset 501 relative to the mainguide wire axis. Offset 501 may be a variable ideally suited for aparticular patient's heart. FIG. 19 shows a length guide wire 600 havinga distance 601 from the end of the curl to the straight section goingthrough natural valve 16. Length 601 can be optimized for a particularpatient's heart and allow guide wire 30 to be pushed against the bottomwall of left ventricle 18 for more optimal location of prosthetic valve42. FIG. 20 shows a bent guide wire 700 having a straight section 702and a bent section 703. Bent section 703 is formed at an angle 701relative to straight section 702. Bent section 703 at angle 701 can beoptimized to a particular patient's heart for better alignment ofprosthetic valve 42 within annulus 17. FIG. 21 shows a coil guide wire800 with a coil section 801. The diameter of coil section 801 and thenumber of turns can be optimized for a particular patient's heart forbetter alignment of prosthetic valve 42 within annulus 17. AlthoughFIGS. 18 through 21 show individual shape variables, an optimal versionof guide wire 30 may be a combination of shapes shown. For instance, anoptimal guide wire may be a combination of offset 501, length 601, bend701 and curl 801. FIGS. 17 to 20 show alternative embodiments of guidewire 30 making them not only suitable for navigating the tortuouspathways of lumens in the body, but optimized to work in the open spacesof the heart.

FIGS. 22 and 23 show yet another alternative embodiment of guide wire 30which may be useful for aligning prosthetic valve 42 within heart 10.Guide wire 400, as shown in the collapsed cross section view of FIG. 23,is comprised of first wire 401, second wire 402 and third wire 403.Together the collapsed wires transverse the tortuous pathways and whenentering the open space of heart 10 they expand as shown in FIG. 22.Expanded wires 401, 402, and 403 make contact with the walls of heart 10and provide a structure to apply forces to align prosthetic heart valve42. It should be appreciated that although three wires are shown, two ormore wires can achieve the desired result. Each wire may have adifferent shape when expanded giving more versatility to align valve 42.

It should be appreciated that individual patient hearts have differentsizes and shapes. Aortic arch 14 may have different bends towardsascending aorta 15 and different diameters. Ascending aorta 15 maytransition to annulus 17 at different angles and the length of annulus17 may vary. The volume of left ventricle 18 can vary as well as itswall locations. As an alternative embodiment, the present invention ofoptimally locating prosthetic valve 42 can be improved by a customprocess 900 which is shown in FIG. 24. Custom process 900 creates acustom guide wire 30 optimized for a particular patient's heart and iscomprised of the following steps:

(1) A heart scan 901, such as a CT scan or an MRI, produces either a twodimensional or three dimensional image model 902 of the patient's heart.

(2) A measurement step 903 utilizes image model 902 to find criticalattributes of the patient's heart which may include diameters, lengths,profiles and angles.

(3) A design step 904 utilizes the critical attributes of measurementstep 903 and applies historical data and algorithms for creatingoptimized shapes of guide wire 30. Simulations of the optimized shapecan be used in conjunction with image model 902 for predicting theperformance of optimized guide wire 30. The output of design step 904may be a two dimensional drawing or a three dimensional computer modelof an optimized guide wire 30.

(4) A fabrication step 905 utilizes common guide wire manufacturingmethods for producing the output of design step 904. The fabricated ofguide wire 30 can be produced at a manufacturing facility and shipped tothe surgery center, or the fabricated product can be produced at thehospital utilizing machines capable of producing bends.

(5) Lastly, a surgical step 906 utilizes the optimized guide wire 30 forsurgery. As previously described, guide wire 30 is inserted in a lumenof the body and moved to the desired surgical location to repaired orreplaced. The optimized version of guide wire 30 more easily navigatesthe lumens due to its unique shape and stiffness. In the case of heartvalve replacement, the optimized version of guide wire 30 makes contactwith tissue and the optimal shape and stiffness ideally positionsprosthetic valve 42 within the particular patient's heart. The use ofguide wire control device 60 in combination with optimized version ofguide wire 30 gives the surgeon much control and accuracy over currentmethods. The goal is to improve the speed and locational accuracy ofprosthetic valve 42 while reducing the risk of tissue damage to heart10.

Other manufacturing embodiments of the present invention are possibleand all within the sprit and scope of the present invention. Forinstance, translating assembly 80 is shown as the best mode of thepresent invention. The best mode is shown in a way to provide thedesired function, but also to allow low cost injection moldingmanufacturing methods. It should be appreciated that other manufacturingmethods can result in a different and optimized construction. Forinstance, translational assembly 80 may be a single part manufacturedwith spring 110 within. As another example, actuator 100 may befabricated as part of sliding member 86 a and, or, 86 b. It is possibleto 3D print translational assembly 80 in one part that includes thefunction of spring 110. Spring 110 does not have to be produced from ametallic material to provide the desired function or flexibly engagingwith stationary assembly 70, alternatively spring 100 may constructedfrom a polymeric material. Alternative to the construction describedherein, it should be appreciated that the controlled displacementbetween translational assembly 80 and stationary assembly 70 isaccomplished with a spring and a groove which provide the means ofvariably engaging translational assembly 80 and stationary assembly 70.Rather than utilize a spring on translational assembly 80 and grooves instationary member 70, stationary assembly 70 may contain a spring andtranslational assembly 80 may contain grooves. All construction methodsfall within the sprit and scope of the present invention.

While the catheter guide wire control device and related methodsdescribed herein constitute preferred embodiments of the invention, itis to be understood that the invention is not limited to these preciseform of assemblies, and that changes may be made therein withoutdeparting from the scope and spirit of the invention as defined in theappended claims.

I claim:
 1. A method of utilizing a guide wire for a surgical processwhich comprises: (a) scanning an anatomy of a patient to generate animage; (b) measuring said image to determine one or more anatomicalattributes; (c) forming a guide wire optimized for said one or moreanatomical attributes; and, (d) utilizing said guide wire a s part of asurgical procedure within said patient.
 2. The method of claim 1,wherein said utilizing step includes managing said guide wire with acontrol device releasably attached to said guide wire.
 3. The method ofclaim 1, wherein said forming step includes bending a section of saidguide wire into an offset shape.
 4. The method of claim 1, wherein saidforming step includes bending a section of said guide wire into anon-linear shape.
 5. The method of claim 1, wherein said forming stepincludes bending a section of said guide wire into a coil shape.
 6. Themethod of claim 1, wherein said forming step includes combining aplurality of wire strands to create said guide wire.
 7. A method ofutilizing a guide wire for a surgical process which comprises: (a)scanning a heart of a patient to generate an image; (b) measuring saidimage to determine one or more anatomical attributes of said heart andat least one artery; (c) forming a guide wire optimized for said one ormore anatomical attributes; and, (d) utilizing said guide wire as partof a surgical procedure within said patient.
 8. The method of claim 7,wherein said utilizing step includes managing said guide wire with acontrol device releasably attached to said guide wire.
 9. The method ofclaim 7, wherein said forming step includes bending a section of saidguide wire with an offset.
 10. The method of claim 7, wherein saidforming step includes bending a section of said guide wire into anon-linear shape.
 11. The method of claim 7, wherein said forming stepincludes bending a section of said guide wire into a coil shape.
 12. Themethod of claim 7, wherein said forming step includes combining aplurality of wire strands to create said guide wire.
 13. The method ofclaim 7, wherein said utilizing step includes making said guide wireextend through said artery and make contact with a wall of said heart.14. A method of utilizing a guide wire for a surgical process whichcomprises: (a) scanning a patient to generate an image of said patent'sheart and a lumen connected to said heart; (b) measuring said image todetermine one or more anatomical attributes of said heart and saidlumen; (c) forming a guide wire optimized for said one or moreanatomical attributes; and, (d) utilizing said guide wire as part of asurgical procedure within said patient.
 15. The method of claim 14,wherein said utilizing step includes managing said guide wire with acontrol device releasably attached to said guide wire.
 16. The method ofclaim 14, wherein said forming step includes bending a section of saidguide wire with an offset.
 17. The method of claim 14, wherein saidforming step includes bending a section of said guide wire into anon-linear shape.
 18. The method of claim 14, wherein said forming stepincludes bending a section of said guide wire into a coil shape.
 19. Themethod of claim 14, wherein said forming step includes combining aplurality of wire strands to create said guide wire.
 20. The method ofclaim 14, wherein said utilizing step includes making said guide wireextend through said artery and make contact with a wall of said heart.